Strides Pharma receives USFDA approval for anti-inflammatory drug

Strides Pharma Science on Wednesday announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Ibuprofen oral suspension USP, 100 mg/5 mL (OTC) from the United States Food & Drug Administration.

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Children's Motrin oral suspension, 100 mg/mL, of Johnson & Johnson Consumer Inc.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain from various conditions such as headache, dental pain, muscle aches. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu.

Strides said it is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules, topicals, powders and oral solutions. The latest approval will further strengthen its private label portfolio for the US market.

According to IRi data, the US market for Ibuprofen oral suspension USP, 100 mg/5 mL (OTC) is approximately $133 million. The product will be manufactured at the company's facility at Bengaluru.

The company has 127 cumulative ANDA filings with USFDA of which 99 ANDAs have been approved and 28 are pending approval.

Shares of Strides Pharma were trading 0.32% higher at Rs 855.8 on BSE.

Strides Pharma Science is a global pharmaceutical company. It focuses on "difficult to manufacture" products that are sold in over 100 countries. The company has 127 cumulative ANDA filings with USFDA of which 99 ANDAs have been approved and 28 are pending approval.

On a consolidated basis, the pharma company posted a 61.9% fall in net profit to Rs 35.16 crore on a 13.6% rise in net sales to Rs 832 crore in Q3 FY21 over Q3 FY20.

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